The present invention relates generally to medical apparatus and methods and more particularly to devices and methods for the minimally invasive approximation of muscle, fascia or other tissue such as approximation of the rectus muscles in the abdomen (abdominoplasty), hernia repair, closing fascial defects and other such applications where fascia or other tissue structures need approximating, that provide patient benefit using minimally invasive techniques that, among other benefits, reduce or eliminate visible scars.
In the case of diastasis of the rectus muscle and ventral hernias, separation of muscles and fascia from each other can occur over time due to stretching or weakening of tissue, resulting in protrusion at the region of separation of otherwise contained material, e.g. fat, tissue, or intestine. For example, during pregnancy or over time with weight gain, the rectus abdominals muscles, (the large muscles that run longitudinally along the abdomen from the torso to the groin of a human being), can diverge from each other, resulting in a flabby appearance or in some cases protrusion of accumulated fat or other structures through the separated region. Many people desire to undergo surgical repair of the separated muscles either to repair the herniation of material, or in less extreme cases, purely for cosmetic reasons, sometimes in conjunction with liposuction or removal of excess skin and fatty tissue.
Historically, procedures such as abdominoplasty have been performed through a large open surgical incision in the abdomen, through which surgical tools are introduced to dissect away the subcutaneous tissue and fat from the abdominal fascia, and then directly reapproximating the medial borders of the rectus sheath, usually using sutures. Other methods for approximating fascia or otherwise joining body tissue are also known. For example, U.S. Pat. No. 5,125,553 describes a surgical instrument for joining body tissue for stapling a hernial opening in internal tissues of a patient. U.S. Pat. No. 4,127,227 describes a staple cartridge for applying staples to a large amount of fascia in a patient.
More recently, surgeons have performed abdominoplasty endoscopically by gaining access through a patient""s umbilicus with the aid of a retractor and endoscope, and by making a smaller incision in the xe2x80x9cbikini linexe2x80x9d area to allow access for various surgical tools to dissect the muscles from the rectus fascia, as well as stapling tools to plicate the rectus fascia or suture the muscles together. As an example, U.S. Pat. Nos. 5,329,943 and 5,655,544 describe an endoscopic procedure for performing an abdominoplasty through two small incisions at the umbilicus and the xe2x80x9cbikini linexe2x80x9d areas of the patient. Approximation of the muscle and tissue is achieved by the use of a tenaculum (curved tip, sharp hemostat) and sutures or a stapling gun.
The abdominoplasty procedure can also be performed in conjunction with other procedures, such as liposuction, hernia repair or other reconstructive surgery.
While these techniques have been successful, there is a need for improved devices and methods for more efficiently performing procedures such as abdominoplasty that further reduce post-procedure scarring and allow for more rapid and comfortable patient recovery. It would be desirable to have a system of devices that allowed a physician to directly access the treatment site without leaving any visible scarring. Furthermore, it would be desirable to have a system of devices and methods that allowed tissue approximation procedures to be performed without the necessity of dissecting the subcutaneous tissue from the rectus fascia, thereby reducing trauma to the patient and speeding recovery time.
Such improved tools could access through a smaller incision, preferably at the umbilicus, where no visible scarring would ensue, and without the necessity of a second incision for visualization tools or other device maneuvers. In addition, to speed recovery time it would be desirable to focus the penetration and pulling together of fascia, directly on the fascia sheaths with minimal disruption of the rectus muscles themselves. Furthermore, it would be desirable to have tools that allow approximation of fascia even in the absence of a continuous loop of fascia, or in the case where the posterior rectus sheath does not fully extend or is not continuous in the area to be treated. This can be the case in the suprapubic region (below the umbilicus) where only the anterior portion of the rectus sheath extends.
Although such tools would be useful to approximate the tissue so that traditional suturing methods could be employed, it would also be desirable to have a system that included an implantable fastening member releaseably secured to the end of the tool for placement once the desired location of approximation is attained. It would furthermore be desirable for such devices to generate sufficient force to bias the fascia together as well as to deploy the fastener device to secure the fascia in its new position. Additionally, improved methods would be desirable for accessing the points of approximation through the rectus sheath of the abdominal rectus muscle, from within the fascia, as opposed to dissecting the subcutaneous tissue from the fascia more invasively and placing the approximating fasteners externally.
These and other objectives are met by the design and use of the various embodiments of the present invention, as detailed herein.
According to the present invention, improved methods and apparatus are provided for approximating tissue, fascia, muscle and the like. A first embodiment of the present invention provides a tissue approximating device or applicator tool, for use as a stand-alone device or tool or as part of a kit, for performing a minimally invasive abdominoplasty or similar procedure. The kit includes fastener devices, such as rivets or grommets, that can be placed from either side of a tissue surface while at the same time minimizing necessary exposed tissue surface and incision length in the patient. The applicator tool has opposing surfaces or jaws that are mounted for movement toward and away from one another by actuation of a handle member.
In an exemplary use of the present invention, a surgeon makes an incision along the margins of the umbilicus and makes an incision into the medial border of the rectus fascia of a patient and locates each jaw of the applicator tool into the envelope formed by the rectus sheath that surrounds the abdominus rectus muscles. This sheath encapsulates each length of abdominal muscle allowing each of the jaws to follow along the path formed between the sheath and the muscle, thereby minimizing the need for direct visualization once the tool is placed. Once located in their respective sheaths, the jaws of the tool can be advanced to the location where the first fastener is to be placed. The device can also be palpated from the skin surface by the surgeon to determine the location of the distal end of the tool relative to the muscle separation which has been previously determined. After placement of the first fastener, the procedure is repeated until the separated length of the abdominus rectus muscle has been approximated.
The present invention also incorporates an automated feature for releasing the fastening devices. The fastening devices can be formed in a series, such as in a cartridge, for easy loading into the jaws of the application tool. Alternatively, multiple fasteners can be deployed simultaneously from multiple deployment sites along the jaw of the applicator tool. The fastening devices may be formed of various materials and construction, including varying sizes, shapes and compositions.
In a yet another embodiment, the applicator tool distal jaw section may be formed in a notched configuration having a reciprocal tooth and cavity arrangements such that when the jaws of the tool are brought together, the distal ends of each tip reciprocally engage the other at the opposing notched or toothed section. The teeth contain recessed passageways, also referred to herein as xe2x80x9crecessesxe2x80x9d that allow the placement of a single fastening device in the longitudinal direction through tissue, as opposed to several fasteners deployed axially.
In a further embodiment, the applicator tool may be used simply to approximate the tissue or fascia without the secondary function of deploying a staple or other fastening device. In this embodiment, once the tissue is approximated using the biasing tool of the present invention, standard, suturing techniques may be employed to secure the tissue.